Pazopanib for Carcinoid Tumor

Recruiting in Palo Alto (17 mi)

+495 other locations

Overseen by Emily K Bergsland

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Emily K Bergsland

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

Adults with low or intermediate-grade neuroendocrine carcinoid tumors that can't be surgically removed or have spread, and show signs of progression. Participants must not have high-grade variants, significant recent cardiovascular issues, uncontrolled blood pressure, bleeding risks, immune compromise conditions, or certain gastrointestinal problems. Pregnant women and those on strong CYP3A4 inhibitors are excluded.

Inclusion Criteria

No concurrent condition resulting in immune compromise

Your heart's pumping ability is strong (ejection fraction > 50%).

I am 18 years old or older.

Exclusion Criteria

I have symptoms of poor blood flow in my limbs.

Pregnancy or nursing

My blood clotting time is slightly higher due to my anticoagulant medication.

Treatment Details

Interventions

• Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor)

Trial Overview The trial is testing the effectiveness of Pazopanib Hydrochloride in slowing down or stopping tumor growth compared to a placebo. It's randomized and includes various assessments like echocardiography and MRI to monitor heart function and tumor changes.

Participant Groups

Group I: Arm I (pazopanib hydrochloride) Experimental Treatment 9 Interventions

Patients receive pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.

Group II: Arm II (placebo) Placebo Group 9 Interventions

Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School